Voorham, JacoBaldi, SimonettaSantoro, LuigiKerkhof, MarjanContoli, MarcoFabbri, Leonardo MKerstjens, Huib A MLuis López-Campos, JoseRoche, NicolasSingh, DaveVogelmeier, Claus FPrice, David B2023-02-092023-02-092020-10-29http://hdl.handle.net/10668/16549This study aimed to evaluate the non-inferiority of initiating extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) versus double bronchodilation (long-acting beta-agonists [LABA]/long-acting muscarinic antagonists [LAMA]) among patients with a history of chronic obstructive pulmonary disease (COPD) exacerbations. A historical cohort study was conducted using data from the UK's Optimum Patient Care Research Database. Patients with COPD ≥40 years at diagnosis were included if they initiated extrafine BDP/FF or any LABA/LAMA double therapy as a step-up from no maintenance therapy or monotherapy with inhaled corticosteroids (ICS), LAMA, or LABA and a history of ≥2 moderate/severe exacerbations in the previous two years. The primary outcome was exacerbation rate from therapy initiation until a relevant therapy change or end of follow-up. Secondary outcomes included rate of acute respiratory events, acute oral corticosteroids (OCS) courses, and antibiotic prescriptions with lower respiratory indication, modified Medical Research Council score (mMRC) ≥2, and time to first pneumonia diagnosis. The non-inferiority boundary was set at a relative difference of 15% on the ratio scale. Five potential treatment effect modifiers were investigated. A total of 1735 patients initiated extrafine BDP/FF and 2450 patients initiated LABA/LAMA. The mean age was 70 years, 51% were male, 41% current smokers, and 85% had FEV1 This study found that stepping up to extrafine BDP/FF from no maintenance or monotherapy was not inferior to stepping up to double bronchodilation therapy in patients with a history of exacerbations.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/chronic obstructive pulmonary diseasecomparative effectivenesselectronic health recordsheterogeneityobservationalreal-worldAdministration, InhalationAdrenergic beta-2 Receptor AgonistsAgedBeclomethasoneBronchodilator AgentsCohort StudiesFormoterol FumarateHumansMaleMuscarinic AntagonistsPulmonary Disease, Chronic Obstructiveresearch article33149571open access10.2147/COPD.S2692871178-2005PMC7605609https://www.dovepress.com/getfile.php?fileID=63131https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605609/pdf